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Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

Primary Purpose

Idiopathic Macular Hole, Effective Prone Time

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Face-down position time 1-day
Face-down position time 3-day
Sponsored by
Tianjin Medical University Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Macular Hole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18 years or older; Patients diagnosed with IMH; Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery; Agreed to the study protocol. Exclusion Criteria: Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm; Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology; Previous history of internal eye surgery in the operated eye; Patients with local or systemic other diseases significantly affecting visual function; Those who cannot maintain face-down position after surgery due to systemic factors, etc.

Sites / Locations

  • Tianjin medical university eye hosipitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Face-down position time 1-day group

Face-down position time 3-day group

Arm Description

Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.

Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.

Outcomes

Primary Outcome Measures

Macular hole closure rate
Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery
Effective face-down position time
Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time.

Secondary Outcome Measures

Best corrected visual acuity change (BCVA)
BCVA for patients after macular fissure surgery, expressed using the (ETDRS) Alphabet Chart.
Retinal nerve fiber layer thickness change
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Macular ganglion cell complex thickness change (GCL+, GCL++)
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Mean retinal Sensitivity (MS)
Micro Perimeter 3
Central 2˚ and 4˚ fixation
Micro Perimeter 3

Full Information

First Posted
February 14, 2023
Last Updated
February 23, 2023
Sponsor
Tianjin Medical University Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05757349
Brief Title
Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery
Official Title
A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macular Hole, Effective Prone Time

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Face-down position time 1-day group
Arm Type
Experimental
Arm Description
Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.
Arm Title
Face-down position time 3-day group
Arm Type
Active Comparator
Arm Description
Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.
Intervention Type
Behavioral
Intervention Name(s)
Face-down position time 1-day
Intervention Description
Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.
Intervention Type
Behavioral
Intervention Name(s)
Face-down position time 3-day
Intervention Description
Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.
Primary Outcome Measure Information:
Title
Macular hole closure rate
Description
Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery
Time Frame
6 month postoperatively
Title
Effective face-down position time
Description
Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time.
Time Frame
1 or 3 day postoperatively
Secondary Outcome Measure Information:
Title
Best corrected visual acuity change (BCVA)
Description
BCVA for patients after macular fissure surgery, expressed using the (ETDRS) Alphabet Chart.
Time Frame
1, 3, 6 month postoperatively
Title
Retinal nerve fiber layer thickness change
Description
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Time Frame
1, 3, 6 month postoperatively
Title
Macular ganglion cell complex thickness change (GCL+, GCL++)
Description
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Time Frame
1, 3, 6 month postoperatively
Title
Mean retinal Sensitivity (MS)
Description
Micro Perimeter 3
Time Frame
1, 3, 6 month postoperatively
Title
Central 2˚ and 4˚ fixation
Description
Micro Perimeter 3
Time Frame
1, 3, 6 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older; Patients diagnosed with IMH; Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery; Agreed to the study protocol. Exclusion Criteria: Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm; Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology; Previous history of internal eye surgery in the operated eye; Patients with local or systemic other diseases significantly affecting visual function; Those who cannot maintain face-down position after surgery due to systemic factors, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bojie Hu
Phone
13612130943
Email
bhu07@tmu.edu.cn
Facility Information:
Facility Name
Tianjin medical university eye hosipital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojie Hu
Phone
13612130943
Email
bhu07@tmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

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